Identity
- Trade Name
- WaterPAP FDA UDI
- Generic Name
- Mechanical expiratory valve, single-use FDA UDI
- Device Name
- Positive Airway pressure device FDA UDI
- Model / Reference
- WP-7700 FDA UDI
- Description
- Positive Airway pressure device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862146000302 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- Mechanical expiratory valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5965 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mechanical expiratory valve, single-use
WaterPAP by Airways Development, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical expiratory valve, single-use.
- Expiratory valve set — HAMILTON MEDICAL, INC. · Class I
- ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG — MAGNAMED TECNOLOGIA MEDICA SA · Class I
- Valve, Bleed Tail — WESTMED, INC. · Class II
- Expiratory valve set — HAMILTON MEDICAL, INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Expiratory valve set — HAMILTON MEDICAL, INC. · Class I
- Expiratory valve set — HAMILTON MEDICAL, INC. · Class I
- WaterPAP PRO — Airways Development, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Airways Development, LLC
Sources (1)
- FDA UDI eced8ea7-befc-4c83-972d-f3fa59c90ffe 33 fields · synced May 30, 2026